Note: Administer all live or live-attenuated vaccines at least 4 weeks prior, and non-live vaccines at least 2 weeks prior to initiation of satralizumab. Assess patients for presence of any active infection; delay treatment until active infection is resolved. Screen for hepatitis B (hepatitis B surface antigen [HBsAg] and hepatitis B core antibody [HBcAb]) prior to initiation; do not administer to patients with active hepatitis B. Evaluate for active/latent tuberculosis (TB) prior to initiation; for patients with active TB or positive TB screening without a history of appropriate treatment, consult infectious disease specialist before initiating treatment. Assess ALT/AST and serum bilirubin prior to initiation; use with caution if ALT/AST >1.5 times ULN.
Neuromyelitis optica spectrum disorder: SubQ: Loading dose: 120 mg once every 2 weeks for 3 doses (weeks 0, 2, and 4), followed by maintenance dose: 120 mg once every 4 weeks.
Dosage for delayed or missed doses (reasons other than increased liver enzymes):
Missed loading dose: 120 mg as soon as possible (do not wait until next planned dose). If the second loading dose is delayed or missed, administer as soon as possible and administer the third (final) loading dose 2 weeks later. If the third loading dose is delayed or missed, administer as soon as possible and administer the first maintenance dose 4 weeks later.
Missed maintenance dose:
If <8 weeks since last dose: 120 mg as soon as possible (do not wait until the next planned dose). Reset dose schedule to every 4 weeks after delayed or missed dose administered.
If 8 to <12 weeks since last dose: 120 mg every 2 weeks for 2 doses (weeks 0 and 2), followed by 120 mg every 4 weeks. Note: “Week 0” refers to time of the first administration after the missed dose.
If ≥12 weeks since last dose: 120 mg every 2 weeks for 3 doses (weeks 0, 2, and 4), followed by 120 mg every 4 weeks. Note: “Week 0” refers to time of the first administration after the missed dose.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Hepatic impairment prior to treatment initiation: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Use caution in patients with baseline ALT/AST >1.5 × ULN.
Hepatotoxicity during treatment:
ALT/AST >5 × ULN and any bilirubin elevation: Discontinue therapy; reinitiation not recommended.
ALT/AST >5 × ULN and not associated with bilirubin elevation: Interrupt therapy until ALT/AST return to normal range, then restart as follows:
If <12 weeks since last dose: Administer 120 mg every 4 weeks.
If ≥12 weeks since last dose: Administer 120 mg every 2 weeks for 3 doses (weeks 0, 2, and 4) followed by 120 mg every 4 weeks. Note: “Week 0” refers to time of the first administration after the missed dose.
Note: Monitor LFTs closely and discontinue therapy without reinitiation if subsequent increases in ALT/AST and/or bilirubin above ULN occur.
Refer to adult dosing; use with caution.
Decreased neutrophil count: Neutrophil count <1,000/mm3 (confirmed by repeat testing): Interrupt therapy until neutrophil count returns to >1,000/mm3.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Enspryng: Satralizumab-mwge 120 mg/mL (1 mL)
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous:
Enspryng: 120 mg/mL (1 ea)
SubQ: Prior to use, remove prefilled syringe from refrigeration and carton and allow to sit at room temperature for 30 minutes; do not warm product in any other way. Administer the full amount in the prefilled syringe (1 mL). Administer subcutaneously into the abdomen or thigh. Rotate injection sites with each administration; avoid injecting into moles, scars, or tender, bruised, red, or hard skin. After proper training, patients may self-inject, or the patient's caregiver may administer satralizumab.
Neuromyelitis optica spectrum disorder: Treatment of neuromyelitis optica spectrum disorder in adults who are anti-aquaporin-4 (AQP4) antibody positive.
Mild to moderate elevations in liver enzymes have occurred commonly, including increased serum alanine aminotransferase and increased serum aspartate aminotransferase with or without increased bilirubin. The majority of reported cases were transient and/or resolved without dose interruption (Ref). May require dosage adjustment, treatment interruption, or treatment discontinuation.
Onset: Not well characterized; in 1 patient, elevations of ALT >5 times the upper limit of normal were observed 4 weeks after initiation of therapy.
Decreased platelet counts and neutropenia may commonly occur. The majority of reported cases were transient and/or resolved without dose interruption (Ref).
Hypersensitivity reactions, including anaphylaxis (fatal), skin rash, and urticaria, have occurred with other interleukin-6 (IL-6) receptor antagonists; anaphylaxis was not seen with satralizumab in clinical trials (Ref).
Interleukin-6 (IL-6) receptor antagonists, including satralizumab, have immunosuppressive effects that are reversible with discontinuation. An increased risk of infection (including severe infections or potentially fatal infections) has been observed with satralizumab; an increased risk for cellulitis, nasopharyngitis, upper respiratory tract infection, and pharyngitis was noted in clinical trials. Clinicians should be aware of the potential for hepatitis B virus (HBV) reactivation or tuberculosis that exists with the use of immunosuppressant therapies, including IL-6 receptor antagonists.
Mechanism: Dose- and time-related; related to pharmacologic action (ie, immunosuppressive effects)
Risk factors:
• Presence of active infection, including localized infections
• Tuberculosis: Preexisting tuberculosis risk factors; latent tuberculosis infection
• HBV reactivation: Chronic carriers of HBV [HBsAg+]; patients who are negative for HBsAg and positive for HB core antibody [HBcAb+]
The following adverse drug reactions and incidences are derived from product labeling and without concurrent immunosuppressive therapy unless otherwise specified.
>10%:
Dermatologic: Skin rash (17%) (table 1)
Drug (Satralizumab) |
Placebo |
Number of Patients (Satralizumab) |
Number of Patients (Placebo) |
---|---|---|---|
17% |
0% |
41 |
23 |
Endocrine & metabolic: Increased serum cholesterol (12%; defined as total cholesterol >300 mg/dL), increased serum triglycerides (27%; defined as triglycerides >300 mg/dL), weight gain (28%)
Gastrointestinal: Gastritis (with concurrent immunosuppressant therapy: 15%), nausea (15%)
Hematologic & oncologic: Decreased platelet count (26%; with concurrent immunosuppressant therapy: 35%) (table 2) , neutropenia (10%; with concurrent immunosuppressant therapy: 15%) (table 3)
Drug (Satralizumab) |
Placebo |
Number of Patients (Satralizumab) |
Number of Patients (Placebo) |
Comments |
---|---|---|---|---|
35% |
17% |
26 |
26 |
With concurrent immunosuppressant therapy |
26% |
5% |
41 |
23 |
N/A |
Drug (Satralizumab) |
Placebo |
Number of Patients (Satralizumab) |
Number of Patients (Placebo) |
Comments |
---|---|---|---|---|
15% |
4% |
26 |
26 |
With concurrent immunosuppressant therapy |
10% |
9% |
41 |
23 |
N/A |
Hepatic: Increased serum alanine aminotransferase (43%; with concurrent immunosuppressant therapy: 8%) (table 4) , increased serum aspartate aminotransferase (25%; with concurrent immunosuppressant therapy: 8%) (table 5)
Drug (Satralizumab) |
Placebo |
Number of Patients (Satralizumab) |
Number of Patients (Placebo) |
Comments |
---|---|---|---|---|
43% |
13% |
41 |
23 |
N/A |
8% |
12% |
26 |
26 |
With concurrent immunosuppressant therapy |
Drug (Satralizumab) |
Placebo |
Number of Patients (Satralizumab) |
Number of Patients (Placebo) |
Comments |
---|---|---|---|---|
25% |
9% |
41 |
23 |
N/A |
8% |
19% |
26 |
26 |
With concurrent immunosuppressant therapy |
Immunologic: Antibody development (73%)
Infection: Infection (54%; including severe infection: 10%) (Traboulsee 2020) (table 6)
Drug (Satralizumab) |
Placebo |
Number of Patients (Satralizumab) |
Number of Patients (Placebo) |
Source |
---|---|---|---|---|
54% |
44% |
63 |
32 |
Traboulsee 2020 |
Severe: 10% |
9% |
63 |
32 |
Traboulsee 2020 |
Nervous system: Fatigue (15%), headache (with concurrent immunosuppressant therapy: 27%)
Neuromuscular & skeletal: Arthralgia (17%), limb pain (15%)
Respiratory: Nasopharyngitis (12%; with concurrent immunosuppressant therapy: 31%) (table 7) , pharyngitis (with concurrent immunosuppressant therapy: 12%) (table 8) , upper respiratory tract infection (with concurrent immunosuppressant therapy: 19%) (table 9)
Drug (Satralizumab) |
Placebo |
Number of Patients (Satralizumab) |
Number of Patients (Placebo) |
Comments |
---|---|---|---|---|
31% |
15% |
26 |
26 |
With concurrent immunosuppressant therapy |
12% |
4% |
41 |
23 |
N/A |
Drug (Satralizumab) |
Placebo |
Number of Patients (Satralizumab) |
Number of Patients (Placebo) |
Comments |
---|---|---|---|---|
12% |
8% |
26 |
26 |
With concurrent immunosuppressant therapy |
Drug (Satralizumab) |
Placebo |
Number of Patients (Satralizumab) |
Number of Patients (Placebo) |
Comments |
---|---|---|---|---|
19% |
12% |
26 |
26 |
With concurrent immunosuppressant therapy |
1% to 10%:
Dermatologic: Cellulitis (10%) (table 10) , pruritus (10%)
Drug (Satralizumab) |
Placebo |
Number of Patients (Satralizumab) |
Number of Patients (Placebo) |
---|---|---|---|
10% |
0% |
41 |
23 |
Local: Injection site reaction (including injection site pruritus and residual mass at injection site)
Nervous system: Depression (10%), falling (10%)
Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (10%)
Frequency not defined:
Endocrine & metabolic: Decreased serum fibrinogen
Gastrointestinal: Diarrhea
Hematologic & oncologic: Disorder of hemostatic components of blood (reduction in C3 and C4 complement levels)
Hypersensitivity to satralizumab or any component of the formulation; active hepatitis B infection; active or untreated latent tuberculosis.
Other warnings/precautions:
• Immunizations: Immunization with live-attenuated or live vaccines is not recommended during therapy.
None known.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: In the US, after receipt of the single dose COVID-19 adenovirus vector vaccine (Janssen), administer an additional 2nd dose using an mRNA COVID-19 vaccine, at least 28 days after the primary vaccine dose, in patients taking immunosuppressive therapies. Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Consider administration of a 3rd dose of COVID-19 vaccine, at least 28 days after completion of the primary 2-dose series, in patients 5 years of age and older taking immunosuppressive therapies. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
CYP2C9 Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Interleukin-6 (IL-6) Inhibiting Therapies may decrease the serum concentration of CYP2C9 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Interleukin-6 (IL-6) Inhibiting Therapies may decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Echinacea: May diminish the therapeutic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Management: Consider avoiding echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Risk D: Consider therapy modification
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If post-exposure rabies vaccination is required during immunosuppressant therapy, administer a 5th dose of vaccine and check for rabies antibodies. Risk D: Consider therapy modification
Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Satralizumab is a humanized monoclonal antibody (IgG2). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Maternal neuromyelitis optica spectrum disorder (NMOSD) may be associated with adverse pregnancy outcomes. Information related to the treatment of NMOSD in pregnancy is limited; agents other than satralizumab may be preferred (Borisow 2018; Chang 2020; Kim 2020; Zhu 2020).
It is not known if satralizumab is present in breast milk. However, satralizumab is a humanized monoclonal antibody (IgG2); human IgG is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Hepatitis B virus screening (hepatitis B surface antigen [HBsAg] and hepatitis B core antibody [HBcAb] tests prior to therapy initiation); active/latent tuberculosis (TB) evaluation and risk factor assessment (prior to initiation), signs/symptoms of TB (throughout treatment); ALT/AST (prior to initiation, every 4 weeks for the first 3 months of treatment, then every 3 months for 1 year, and then as clinically warranted); serum bilirubin (prior to initiation and as clinically warranted); neutrophil counts (4 to 8 weeks after initiation and then at regular clinically determined intervals); signs/symptoms of any active infection (prior to each treatment).
Satralizumab is an antagonist of the interleukin-6 (IL-6) receptor. Satralizumab is presumed to inhibit IL-6-mediated signaling through binding to soluble and membrane-bound IL-6 receptors.
Distribution: Central Vd: ~3.5 L; peripheral Vd: ~2 L.
Bioavailability: 85%.
Half-life elimination: ~30 days (range: 22 to 37 days).
Solution Prefilled Syringe (Enspryng Subcutaneous)
120 mg/mL (per mL): $18,064.62
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